A Trial Of CVX-060, An Anti-Angiogenic COVX-Body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Solid Tumor

Treatments: Drug: Sunitinib; Drug: CVX-060 + sunitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00982657

CVX-060-102 (Other Identifier)

B1131001

2010-022657-42 (EudraCT Number)

Details and patient eligibility

About

The safety and tolerability of CVX-060 have been established in the first-in-human clinical trial, CVX-060-101. Thus, this phase Ib/II trial is to assess the safety and pharmacokinetics (PK) profiles of combining CVX-060 with sunitinib in patients with advanced solid tumors, and to subsequently assess the treatment efficacy of the combination treatment, as well as that of sunitinib alone in patients with advanced renal cell carcinoma (mRCC).

Full description

On 23-Nov-2010, B1131001 (CVX-060-102) was closed to enrollment due to emerging clinical data which led to a re-assessment of the strategic goals of the PF-04856884 program. The study enrolled the Phase 1b portion only. Subsequently, on 25-Oct-2012, due to data safety signals in a separate clinical trial with PF-04856884 (CVX-060), all PF-04856884 studies were discontinued and ongoing patients on B1131001 were permitted to remain on study at a reduced PF-04856884 dose if determined to have been deriving clinical benefit.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed advanced/metastatic solid tumor
• Having received at least 1 prior systemic therapy for the treatment of advanced/metastatic solid tumors
• Histologically or cytologically confirmed renal cell carcinoma with clear cell histology and evidence of metastasis (No previous systemic therapy for the treatment of metastatic renal cell carcinoma)
• Adequate laboratory tests
• Eastern Cooperative Oncology Group (ECOG) 0-1, Life expectancy > or = 12 weeks and age > or = 18 years

Exclusion criteria

• Patients intolerant of prior anti-angiogenic agents
• Recent history of bleeding or bleeding disorders
• History of tumors in the brain
• History of heart problems
• History of severe allergic reaction to antibody therapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 6 patient groups

Cohort 1

Experimental group

Description:

CVX-060 + sunitinib

Treatment:

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Cohort 2

Experimental group

Description:

CVX-060 + sunitinib

Treatment:

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Cohort 3

Experimental group

Description:

CVX-060 + sunitinib

Treatment:

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Expanded cohort

Experimental group

Description:

CVX-060 + sunitinib

Treatment:

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Phase II - Arm A

Experimental group

Description:

CVX-060 + sunitinib

Treatment:

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Drug: CVX-060 + sunitinib

Phase II - Arm B

Active Comparator group

Description:

sunitinib alone

Treatment:

Drug: Sunitinib